Expertise.
CAPA Management.
Efficient?
Proactive?
Secure?
Do you need support in implementing a CAPA management system?
CAPA-Management Consulting.
Our CAPA management consulting helps you to implement an efficient system for corrective and preventive action that detects deviations at an early stage and enables sustainable process optimization. This allows you to ensure long-term compliance and product quality.
A robust CAPA system is crucial for meeting regulatory requirements in the pharmaceutical industry, medical technology and biotechnology. Our experts support you in effectively eliminating deviations and implementing preventive measures.
Our services include:
- Deviation analysis & corrective measures: Identification of the causes of deviations and immediate implementation of targeted corrective measures.
- Preventive measures & process optimization: Preventive measures to avoid recurring errors and to optimize processes.
- Training & audit preparation: CAPA training for your team and optimization of documentation in preparation for audits.
Our expertise in CAPA management.
Deviation analysis & corrective measures.
- Root cause analysis to identify the causes of deviations
- Implementation of targeted corrective measures
- Documentation optimization for audits
Preventive measures & process optimization.
- Introduction of preventive measures to avoid recurring errors
- Optimization of processes to increase efficiency
- Implementation of a CAPA system to minimize risk
Training & audit preparation.
- Conducting training courses on the correct application of the CAPA system
- Documentation preparation for audit capability
- Support for continuous process monitoring
Successful CAPA management in practice.
Challenge.
A global pharmaceutical company was faced with recurring deviations that jeopardized compliance and threatened to compromise product quality.
Measures.
- Analysis of deviations and implementation of targeted corrective measures
- Introduction of a structured CAPA system for tracking deviations
- Training the team to use the new system
Results.
- 20% reduction in deviations through effective corrective measures
- Increased compliance and improved documentation for upcoming audits
Success.
The company was able to significantly increase its audit capability and ensure long-term compliance.
Challenge.
A medium-sized medical technology company was struggling with recurring deviations that jeopardized their audit preparation.
Measures.
- Implementation of preventive measures to avoid errors
- Optimization of the documentation process and tracking of CAPA measures
- Training employees in the use of the new CAPA system
Results.
- 30% reduction in errors through preventive measures
- Successful audit preparation and documentation optimization
Success.
The company was able to strengthen its audit capabilities and achieve long-term process improvements.
Challenge.
A medical technology company faced challenges when preparing for an upcoming ISO audit. Recurring deviations and a lack of documentation jeopardized the certification.
Measures.
- Carrying out a comprehensive analysis of recurring deviations and developing customized corrective measures
- Implementation of a CAPA system for documenting and tracking deviations
- Training the team on the correct application of the CAPA system and preparation for audits
Results.
- 20% reduction in deviations through targeted corrective and preventive measures
- Successful preparation and completion of the ISO audit without any objections
- Improved transparency and traceability thanks to optimized documentation in the CAPA system
Success.
The company successfully passed the audit and was able to improve its audit readiness in the long term.
Optimize your CAPA management for sustainable quality assurance.
Our CAPA service portfolio.
We use CAPA records to implement strategic improvements in product quality and process safety. This includes integrating CAPA management into your existing quality management system (QMS) to ensure seamless communication between departments and better data integrity. Our goal is for CAPA to be used not only reactively, but also as a strategic tool for long-term quality improvement.